Abstract
AimTo monitor the adverse drug reactions (ADRs) caused by antihypertensive medicines prescribed in a university teaching hospital.MethodsThe present work was an open, non-comparative, observational study conducted on hypertensive patients attending the Medicine OPD of Majeedia Hospital, Jamia Hamdard, New Delhi, India by conducting patient interviews and recording the data on ADR monitoring form as recommended by Central Drugs Standard Control Organization (CDSCO), Government of India.ResultsA total of 21 adverse drug reactions were observed in 192 hypertensive patients. Incidence of adverse drug reactions was found to be higher in patients more than 40 years in age, and females experienced more ADRs (n = 14, 7.29%) than males, 7 (3.64%). Combination therapy was associated with more number of adverse drug reactions (66.7%) as against monotherapy (33.3%). Calcium channel blockers were found to be the most frequently associated drugs with adverse drug reactions (n = 7), followed by diuretics (n = 5), and β-blockers (n = 4). Among individual drugs, amlodipine was found to be the commonest drug associated with adverse drug reactions (n = 7), followed by torasemide (n = 3). Adverse drug reactions associated with central nervous system were found to be the most frequent (42.8%) followed by musculo-skeletal complaints (23.8%) and gastro-intestinal disorders (14.3%).ConclusionsThe present pharmacovigilance study represents the adverse drug reaction profile of the antihypertensive medicines prescribed in our university teaching hospital. The above findings would be useful for physicians in rational prescribing. Calcium channel blockers were found to be the most frequently associated drugs with adverse drug reactions.
Highlights
Adverse drug reactions have been creating headlines over the last forty years since the thalidomide tragedy
A published meta-analysis of the incidence of adverse drug reactions (ADRs) in hospitalized patients concluded that ADRs rank as the fourth to sixth leading cause of death in the United States and the overall incidence of serious ADR accounted for 6.7% of hospitalized patients [8]
According to a study carried out at a private tertiary care hospital in South India, the incidence of ADRs was found to be 1.8%, out of which 12% of suspected ADRs were severe and 49% ADRs were moderate in severity [9]
Summary
Adverse drug reactions have been creating headlines over the last forty years since the thalidomide tragedy. There is no standard definition of an adverse drug reaction (ADR). Studies used their own definitions, which were indistinct and could be causes of mortality and morbidity in health care facilities globally. According to a study carried out at a private tertiary care hospital in South India, the incidence of ADRs was found to be 1.8%, out of which 12% of suspected ADRs were severe and 49% ADRs were moderate in severity [9]. A study by Arulmani et al in India carried out in a secondary care hospital reported an overall 9.8% incidence of ADRs, of which 3.4% of ADRs were associated with hospital admissions [10]. The objective of this study was to monitor the ADRs caused by antihypertensive medicines prescribed in our university teaching hospitals
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